Benesch Intellectual Property Partner Tara Raghavan was featured in The Wall Street Journal’s article, “FDA Wants Safer Cancer Drugs, But Some Startups Fear Unintended Consequences.” Tara discussed the impact of the FDA's Project Optimus initiative, noting that it could extend the drug development process by six to twelve months, potentially increasing costs and challenges for smaller companies.
The article highlights the FDA’s efforts through Project Optimus to encourage drugmakers to re-evaluate cancer drug dosing to balance safety and efficacy better, aiming to reduce unnecessary side effects from high doses. However, some startups worry that the initiative could raise development time and costs, putting them at a disadvantage compared to larger competitors.
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